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510(k) K121441

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) by Bovie Medical Corporation — Product Code HQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2012
Date Received
May 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

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Other clearances for product code HQP

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  • K023506 — SURGICAL MEDICAL DEVICE CAUTERY (January 13, 2004)
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  • K990728 — THERMAL CAUTERY DEVICE, FORCEPS (June 3, 1999)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K945761 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP (April 10, 1995)
  • K945763 — LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (February 7, 1995)
  • K945762 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (February 7, 1995)